The Recall Desk
HighFDA (Devices)·Z-3339-2018·Announced 2018-10-10

B. Braun Perifix FX Catheter Connectors Recalled for Leakage and Disconnection

B. Braun Medical is recalling Perifix FX catheter connectors because they may not stay closed, leading to leakage or disconnection.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a risk of harm (leakage/disconnection) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

B. Braun Medical, Inc. is recalling the CE17TKFPS Perifix FX Cont. Epid Tray-LF, Material Number 332087. This connection device is used by physicians to provide a single access point to a catheter for the delivery of anesthetics and fluids. The recall covers 3,430 units distributed nationwide in the US and in Australia, Canada, Guatemala, and Kuwait.

The recall was initiated because the catheter connectors may not stay closed during use. In some cases, leakage or disconnection of the catheters from the connectors has been observed. The affected units are identified by batch numbers 61592016, 61597459, 61605296, 61612425, 61615747, and 61620773.

Healthcare providers should stop using the affected devices and contact B. Braun Medical, Inc. for instructions on how to return or replace them. Patients who have received anesthesia using these devices should consult their healthcare provider if they have concerns.

The recalled product

Product
CE17TKFPS PERIFIX FX CONT. EPID TRAY-LF, Material Number 332087 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjuncti
Manufacturer
B. Braun Medical, Inc.
Category
Medical Device — Catheter Connectors
Hazard
Affected units
3,430

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Batch: 61592016
  • 61597459
  • 61605296
  • 61612425
  • 61615747
  • 61620773

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 93 recalled by B. Braun Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 93 products in this recall →

Related recalls

Same manufacturer · B. Braun Medical, Inc.

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Same hazard · leakage

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